Label: IMAGE ESSENTIALS OATMEAL MOISTURIZING- dimethicone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 49738-320-18 - Packager: KMART CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 26, 2014
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- ACTIVE INGREDIENT
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- INACTIVE INGREDIENTS
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INGREDIENTS AND APPEARANCE
IMAGE ESSENTIALS OATMEAL MOISTURIZING
dimethicone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49738-320 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 12.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) PETROLATUM (UNII: 4T6H12BN9U) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) CETYL ALCOHOL (UNII: 936JST6JCN) OATMEAL (UNII: 8PI54V663Y) SODIUM CHLORIDE (UNII: 451W47IQ8X) DMDM HYDANTOIN (UNII: BYR0546TOW) SODIUM HYDROXIDE (UNII: 55X04QC32I) BENZYL ALCOHOL (UNII: LKG8494WBH) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49738-320-18 532 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/25/2014 Labeler - KMART CORPORATION (008965873) Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209) Establishment Name Address ID/FEI Business Operations APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(49738-320)